MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - TARGETING SLEEVE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14200110
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "i was covering a short gamma case at (b)(6) hospital and the distal targeter didn't work, the surgeon could not pass the drill through the distal hole." "distal locking on short nail not functioning.The drill was touching the nail, rather than going through it.Free hand technique was used to finish the procedure.".
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event as well as the affected devices must be available in order to determine the root cause of the complaint event.However, based on the provided additional information was the device was put back in service as found to be functional after the procedure, this indicates that most likely a usage related issue did lead to the reported event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "i was covering a short gamma case at (b)(6) hospital and the distal targeter didn't work, the surgeon could not pass the drill through the distal hole."."distal locking on short nail not functioning.The drill was touching the nail, rather than going through it.Free hand technique was used to finish the procedure.".

• Brand Name: GAMMA4 - TARGETING SLEEVE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22205179
• Report Number: 0008031020-2025-00966
• Device Sequence Number: 17813069
• Product Code: HSB
• UDI-Device Identifier: 07613327479911
• UDI-Public: 07613327479911
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 14200110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown